Contact Information

Organization

THE COMMITTEE ON HUMAN RESEARCH

CONSENT PROCESS - CERTIFICATE OF CONFIDENTIALITY

• UCSF Contact Information
• Background
• Procedures

UCSF Contact Information

If you have any questions please contact Lisa Voss, weekdays, 9am to 5pm Pacific Time, at 415-514-2152 (on campus extension 4-2152).

Background

The Certificate of Confidentiality is an agreement between the PI and the respective NIH Institute. Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect the privacy of research subjects by protecting investigators and institutions from being compelled to release information that could be used to identify subjects with a research project. Certificates of Confidentiality are issued to institutions or universities where the research is conducted. They allow the investigator and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

More Background Information and Frequently Asked Questions can be obtained off the NIH website.

Procedures

First: The PI must obtain CHR approval for the study. Please see below if you already have CHR approval and will be applying for a Certificate of Confidentiality.

The wording in the CHR approved consent form should included wording from the Certificate of Confidentiality Application OR wording from the CHR Guidelines:

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings.

Exceptions: A Certificate of Confidentiality does not prevent researchers from voluntarily disclosing information about you, without your consent. For example, we will voluntarily disclose information about incidents such as child abuse, and intent to hurt yourself or others. In addition, a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information. Finally, the Certificate may not be used to withhold information from the Federal government needed for auditing or evaluating Federally funded projects or information needed by the FDA.

If you already have CHR approval:

Since the Certificate of Confidentiality language should not be a part of the IRB approved consent form until the Certificate of Confidentiality is granted, the NIH is accepting a copy of the approved consent form with only the Certificate of Confidentiality language added. This would be submitted in addition to the currently approved consent form. The consent form with the added language does not need to be reviewed by the IRB prior to submitting the Certificate of Confidentiality application packet. If the Certificate of Confidentiality is granted, the PI will then be expected to send the modified consent to the IRB for approval.

Second: The PI submits the following documents to the CHR not Contracts and Grants. The Cover memo should be addressed to the NIH Certificate of Confidentiality Contact or Coordinator at the NIH Institute or Center (ICs) :

a.	Current CHR Approval letter and Consent Form
b.	The Certificate of Confidentiality Application
c.	The Institutional Official signature block should read: _____________________________ Sharon Friend, MS, CIP Director, HRPP University of California, San Francisco, CA 3333 California St., Suite 315 San Francisco, CA 94118
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Third: The PI will:

a.	Keep current records of correspondence with agency and CHR .
b.	Inform the NIH of any modifications or changes to the IRB protocol or consent form.
c.	Submit these changes to the NIH
d.	Be responsible for submitting these changes and maintaining the expiration date

Fourth: The CHR office will:

a.	Have the Institutional Official or designated official sign the Certificate Confidentiality
b.	File the signed copy in the CHR protocol.
c.	Mail the original to NIH via Fed Ex.
d.	Copy the PI on the electronic Fed Ex shipment request. This will also inform the IRB and PI when the shipment has been received by NIH.
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Fifth: NIH will:

a.	Review the Certificate of Confidentiality and provide correspondence of approval or disapproval to both the PI and Institutional official.
b.	The IRB will then file this information with the original application.

If you have any questions please contact Lisa Voss, weekdays, 9am to 5pm Pacific Time, at 415-514-2152 (on campus extension 4-2152).